Amlodipine Tablets 5mg Technical Specification:
Product Name: | Amlodipine Tablets 5mg |
Brand Name: | Generic |
Strength: | 2.5mg, 5mg, 10mg |
Dosage Form: | Tablets (uncoated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 30s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antihypertensive |
Indication: | Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. |
Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Amlodipine Tablets 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine ………. 5mg
Excipients ……………………………… q.s
Color: Ponceau 2R
THERAPEUTIC INDICATIONS:
Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Why Pharmaceuticals?
Experience the assurance of quality and efficacy with Amlodipine Tablets from Taj Pharma. At Taj Pharma, we are dedicated to your health and well-being, and our Amlodipine Tablets exemplify our commitment to excellence in pharmaceuticals. Amlodipine is a trusted medication prescribed by healthcare professionals worldwide to manage high blood pressure (hypertension) and chest pain (angina). Our Amlodipine Tablets are manufactured to the highest pharmaceutical standards, ensuring that you receive a safe and effective treatment option for cardiovascular conditions. With Taj Pharma, you can rely on a pharmaceutical company with a proven track record of producing top-tier medications. We prioritize quality, safety, and patient satisfaction in everything we do. Trust Taj Pharma for Amlodipine Tablets that provide consistent and dependable blood pressure control, helping you lead a healthier life.
Discover why healthcare professionals and patients alike choose Amlodipine Tablets by Taj Pharma. Make the smart choice for your cardiovascular health—choose Taj Pharma for peace of mind and excellence in pharmaceuticals.
What is Amlodipine Tablets and its use?
Amlodipine tablets are a medication used to treat various cardiovascular conditions, primarily high blood pressure (hypertension) and chest pain known as angina. Amlodipine belongs to a class of drugs called calcium channel blockers.
Amlodipine Tablets and their uses:
- Mechanism of Action: Amlodipine works by relaxing the blood vessels, making it easier for the heart to pump blood and for blood to flow more smoothly through the arteries. This helps lower blood pressure and reduce the workload on the heart.
- Treatment of Hypertension: Amlodipine is commonly prescribed to individuals with high blood pressure. It can be used as a single medication or in combination with other antihypertensive drugs to effectively control blood pressure.
- Management of Angina: Amlodipine is also used to treat angina, a condition characterized by chest pain or discomfort caused by reduced blood flow to the heart muscle. By dilating coronary arteries, amlodipine can increase blood supply to the heart, relieving angina symptoms.
- Long-Lasting Effect: A notable feature of amlodipine is its long duration of action, which allows for once-daily dosing, providing continuous blood pressure control.
- Maintenance Therapy: Amlodipine is often prescribed for long-term use to manage chronic conditions. It is essential to take the medication as directed by a healthcare professional, even if you feel well, as hypertension and angina are typically chronic conditions that require ongoing management.
- Consultation with a Healthcare Provider: Amlodipine should only be used under the guidance of a healthcare provider who will determine the appropriate dosage and monitor your response to the medication. Dosage may vary depending on individual factors and the specific condition being treated.
- Potential Side Effects: While amlodipine is generally well-tolerated, it may have side effects in some individuals. Common side effects can include dizziness, swelling of the ankles or feet, and flushing. More severe side effects are rare but can include a rapid or irregular heartbeat, shortness of breath, and allergic reactions. It’s important to report any unusual or severe side effects to your healthcare provider.
- Interaction with Other Medications: Amlodipine may interact with certain medications, so it’s crucial to inform your healthcare provider about all the drugs, supplements, and herbal products you are taking.
Amlodipine tablets are a widely prescribed and effective option for managing hypertension and angina. However, their use should be tailored to each individual’s specific medical needs, and regular follow-up with a healthcare provider is essential to monitor blood pressure and ensure the medication’s effectiveness and safety. Never start or stop taking amlodipine without consulting your healthcare provider.
How does Amlodipine Tablets Work?
Amlodipine tablets work by affecting calcium channels in the cells of blood vessels and the heart. This mechanism of action makes them effective in treating conditions like high blood pressure (hypertension) and angina (chest pain). Here’s how amlodipine works:
- Calcium Channel Blocker: Amlodipine belongs to a class of drugs known as calcium channel blockers. Calcium channels play a crucial role in controlling the flow of calcium ions into muscle cells of the heart and blood vessels.
- Relaxation of Blood Vessels: Amlodipine primarily targets calcium channels in the smooth muscle cells lining the walls of blood vessels (arteries). By blocking these calcium channels, amlodipine inhibits the entry of calcium ions into the cells. This action leads to the relaxation or dilation of the arterial walls.
- Reduced Resistance: As the arterial walls relax and dilate, the blood vessels become wider, allowing blood to flow more easily. This results in a reduction in peripheral vascular resistance, which is the force against which the heart must pump to push blood through the arteries.
- Lowered Blood Pressure: By reducing peripheral vascular resistance and making it easier for the heart to pump blood, amlodipine effectively lowers blood pressure. This is especially beneficial for individuals with hypertension, as it helps to bring their blood pressure within a normal range.
- Improved Blood Flow to the Heart: In addition to its blood pressure-lowering effects, amlodipine can also increase blood flow to the heart muscle. This is particularly important in the treatment of angina, a condition where the heart muscle doesn’t receive enough oxygen due to reduced blood flow. By dilating coronary arteries (the blood vessels that supply the heart), amlodipine helps alleviate chest pain and discomfort associated with angina.
- Long Duration of Action: A notable characteristic of amlodipine is its long duration of action, which allows for once-daily dosing. This means that a single dose of amlodipine can provide consistent blood pressure control and relief from angina symptoms throughout the day.
amlodipine tablets work by blocking calcium channels in the smooth muscle cells of blood vessels and the heart. This action leads to the relaxation of arterial walls, reduced resistance to blood flow, and improved blood supply to the heart, resulting in lowered blood pressure and relief from angina symptoms. Amlodipine is an effective medication for managing hypertension and angina when prescribed and used as directed by a healthcare professional.
Benefits of Amlodipine Tablets:
- Blood Pressure Control: Amlodipine is effective at lowering high blood pressure, helping to reduce the risk of complications associated with hypertension, such as heart attacks, strokes, and kidney problems.
- Angina Relief: Amlodipine is used to treat angina by improving blood flow to the heart muscle, reducing chest pain or discomfort during angina attacks.
- Long-Lasting Effect: Amlodipine has a long duration of action, allowing for once-daily dosing and consistent blood pressure control throughout the day.
- Well-Tolerated: It is generally well-tolerated, and most people can take it without experiencing severe side effects.
Common Side Effects of Amlodipine Tablets:
- Edema (Swelling): Swelling of the ankles, feet, or legs is a common side effect of amlodipine. This is due to the medication’s effect on blood vessel dilation.
- Headache: Some people may experience headaches while taking amlodipine.
- Dizziness: Amlodipine can cause dizziness, especially when standing up quickly. It’s important to rise slowly from a sitting or lying position to minimize this effect.
- Flushing: Some individuals may experience a sensation of warmth or flushing in the face.
- Palpitations: Amlodipine may cause palpitations, which are sensations of rapid, strong, or irregular heartbeats.
- Nausea: Nausea is a less common side effect, but it can occur.
- Fatigue: Some people may experience fatigue or tiredness while taking amlodipine.
- Gastrointestinal Issues: Digestive problems like abdominal pain, constipation, or diarrhea may occur in some cases.
- Rash: Skin rashes or allergic reactions are rare but possible.
- Lightheadedness: Amlodipine can cause a feeling of lightheadedness or fainting, especially when first starting the medication or when the dosage is increased.
It’s essential to communicate openly with your healthcare provider about any side effects or concerns you have while taking amlodipine. They can provide guidance on managing side effects and adjust your treatment plan if necessary. While the majority of individuals tolerate amlodipine well, some may experience side effects, and in rare cases, serious side effects can occur. If you notice any severe or unusual symptoms, seek medical attention promptly.
Frequently asked questions (FAQs) about Amlodipine Tablets:
- What is Amlodipine, and how does it work?
Amlodipine is a medication used to treat high blood pressure (hypertension) and angina (chest pain). It works by relaxing blood vessels and improving blood flow.
- How should I take Amlodipine Tablets?
Follow your healthcare provider’s instructions for dosing and take Amlodipine Tablets as prescribed. It is typically taken once daily, with or without food.
- What should I do if I miss a dose of Amlodipine?
If you miss a dose, take it as soon as you remember. However, if it’s close to your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses.
- Can I drink alcohol while taking Amlodipine?
It’s generally advisable to limit alcohol consumption while taking Amlodipine, as alcohol can lower blood pressure and may increase the risk of side effects.
- Are there any food interactions with Amlodipine?
Amlodipine can be taken with or without food. However, consuming grapefruit or grapefruit juice should be avoided, as it can interact with the medication and lead to increased levels of Amlodipine in the blood.
- Can Amlodipine cause weight gain?
Amlodipine is not typically associated with significant weight gain. However, some individuals may experience mild fluid retention or edema, which can result in temporary weight gain.
- How long does it take for Amlodipine to start working?
Amlodipine may start to lower blood pressure within a few hours, but it may take several weeks of consistent use to achieve its full therapeutic effect.
- Are there any serious side effects I should be aware of?
While rare, serious side effects of Amlodipine can include a rapid or irregular heartbeat, severe dizziness, swelling of the face or throat (indicating an allergic reaction), or a significant drop in blood pressure. Seek medical attention if you experience any of these symptoms.
- Can I stop taking Amlodipine if my blood pressure improves?
It’s important not to stop taking Amlodipine without consulting your healthcare provider, even if your blood pressure improves. Hypertension often requires longterm management, and discontinuing the medication abruptly can lead to a sudden increase in blood pressure.
- Can I take other medications or supplements with Amlodipine?
Amlodipine may interact with certain medications and supplements, so it’s essential to inform your healthcare provider about all the drugs and supplements you are taking to prevent potential interactions.
- Is Amlodipine safe for use during pregnancy or while breastfeeding?
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the use of Amlodipine with your healthcare provider. They can evaluate the risks and benefits and provide guidance.
As Amlodipine Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Amlodipine Tablets product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Amlodipine Tablets Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Amlodipine Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Amlodipine Tablets 2.5mg
B. Amlodipine Tablets 5mg
C. Amlodipine Tablets 10mg
B. Amlodipine Tablets 5mg
C. Amlodipine Tablets 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Amlodipine Besylate Tablets USP 2.5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine ………. 2.5mg
Excipients ……………………………... q.s
Color: Sunset yellow FCF
B. Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………...5mg
Excipients………………………………… q.s
Color: Ponceau 4R
C. Amlodipine Besylate Tablets USP 10mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine …………...10mg
Excipients …………………………………... q.s
Color: Ponceau 2R
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine ………. 2.5mg
Excipients ……………………………... q.s
Color: Sunset yellow FCF
B. Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………...5mg
Excipients………………………………… q.s
Color: Ponceau 4R
C. Amlodipine Besylate Tablets USP 10mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine …………...10mg
Excipients …………………………………... q.s
Color: Ponceau 2R
THERAPEUTIC INDICATIONS:
Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.